FDA.reportPublic FDA data

Application 091525

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZTROPINE MESYLATEBENZTROPINE MESYLATEINJECTABLE;INJECTION1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10858-011benztropine mesylatebenztropine mesylateWintac LimitedANDACurrent
68382-860Benztropine MesylateBenztropine MesylateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-860Benztropine MesylateBenztropine MesylateZydus Pharmaceuticals USA Inc.ANDACurrent
68475-512Benztropine MesylateBenztropine MesylateNavinta LLCANDACurrent
68475-512Benztropine MesylateBenztropine MesylateNavinta LLCANDACurrent